About our e-learning modules

The modern graphic design and easy-to-use interface allows learners to focus on the content. The animated, friendly and fun approach keeps learners interested and engaged, making learning easy.



The modules can be delivered through your Learning Management System (LMS), or ours. Our LMS tracks who has taken the course, how long they took, the questions they got right (and wrong) and their pass percentage. And it automatically produces a certificate to prove the learner has passed the course.
And of course, the training is scalable. We can deal with anything from 1 to 100,000 users.
E-learning Module - ICH E8(R1)
Learning Objectives
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Describe the general principles in E8(R1) General Considerations for Clinical Studies
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Explain Quality by Design and Critical to Quality Factors
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Overview of Clinical Study Design, Planning, Conduct, Analysis and Reporting
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List types of clinical studies performed during the product lifecycle


Course Content
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Efficacy Guidelines
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Designing Quality into Clinical Studies
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Drug Development Planning
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Design Elements and Data Sources
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Study Conduct, Monitoring & Reporting

E-learning Module - Good Clinical Practice (GCP)
Learning Objectives
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Specify the ICH GCP principles that apply to your role
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Identify key ICH GCP responsibilities for the roles of IRB/IEC, sponsor and investigator
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Describe the importance of RBQM in clinical trials


Course Content
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GCP Principles
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RBQM
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IRB/IEC
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Sponsor
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Investigators
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Essential Documents
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Summary and Quiz

E-learning Module - Risk Assessment and Controls
Learning Objectives
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Define RBQM and its importance in the design and conduct of clinical trials
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Determine critical data and processes
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Identify and evaluate risks
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Establish when to control risks and what to consider in risk controls


Course Content
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Risk: The basics
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Critical Variables
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Identification and evaluation of Risks
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Risk Controls
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Summary and Quiz
